Back to results

Modified Limberg Procedure Versus Lateral Advancement Flap With Burrow's Triangle Procedure in the Treatment of Pilonidal Sinus

Primary Purpose

Sacrococcygeal Pilonidal Disease

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Flap Transposition Procedures

About this trial

This is an interventional treatment trial for Sacrococcygeal Pilonidal Disease focused on measuring flap, pilonidal sinus, vas, recurrence

Eligibility Criteria

15 Years - 70 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Clinical diagnosis of Pilonidal Sinus Disease
Must be able to suitable for the surgery

Exclusion Criteria:

Patients with Recurrent Pilonidal Sinus disease
Patient whom is not suitable for surgery

Sites / Locations

Ankara Mevki Military Hospital : General Surgery Department

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Flap Transposition Technique

Arm Description

Flap Transposition Technique

Outcomes

Primary Outcome Measures

Percentage of Participants with a 95% Decrease in Pain Visual Analogue Scale (VAS)

Secondary Outcome Measures

Full Information

NCT ID

NCT02116738

First Posted

April 14, 2014

Last Updated

April 15, 2014

Sponsor

Ankara Mevki Military Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02116738

Brief Title

Modified Limberg Procedure Versus Lateral Advancement Flap With Burrow's Triangle Procedure in the Treatment of Pilonidal Sinus

Official Title

Interventional Study of the Relatively New Surgical Techniques on the Treatment of Pilonidal Sinus Disease

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Completed

Study Start Date

June 2013 (undefined)

Primary Completion Date

August 2013 (Actual)

Study Completion Date

August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ankara Mevki Military Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The investigators want to share our study that is the "Comparison of Modified Limberg Flap Transposition and Lateral Advancement Flap Transposition with Burrow's Triangle in the Surgical Treatment of Sacrococcygeal Pilonidal Sinus.

Detailed Description

Pilonidal Sinus Disease (PSD) is a common and chronic entity of the young adults. So far, many options regarding the surgical treatment of the disease has been described, the consensus about treatment stills remains unsatisfactory, as all the surgical methods have encountered with different rate of recurrences. Our aim in this study is to compare the widely used technique in pilonidal sinus surgical treatment Modified Limberg Flap Transposition and relatively less used technique Lateral Advancement Flap Transposition with Burrow's Triangle, in the terms of VAS scores, recurrence, postoperative complications, surgical site infections in the first 6 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sacrococcygeal Pilonidal Disease

Keywords

flap, pilonidal sinus, vas, recurrence

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Flap Transposition Technique

Arm Type

Experimental

Arm Description

Flap Transposition Technique

Intervention Type

Procedure

Intervention Name(s)

Flap Transposition Procedures

Intervention Description

Modified Limberg Flap Transposition Procedure and Lateral Advancement Flap Transposition with Burrow's Triangle Procedure in The treatment of Pilonidal Sinus Diseases

Primary Outcome Measure Information:

Title

Percentage of Participants with a 95% Decrease in Pain Visual Analogue Scale (VAS)

Time Frame

12 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Clinical diagnosis of Pilonidal Sinus Disease Must be able to suitable for the surgery Exclusion Criteria: Patients with Recurrent Pilonidal Sinus disease Patient whom is not suitable for surgery

Facility Information:

Facility Name

Ankara Mevki Military Hospital : General Surgery Department

City

Ankara

ZIP/Postal Code

06110

Country

Turkey

12. IPD Sharing Statement

Citations:

PubMed Identifier

23173633

Citation

Yuksel BC, Berkem H, Ozel H, Hengirmen S. A new surgical method of pilonidal sinus treatment: a bilaterally paralel elliptic fascio-cutaneous advancement flap technique. Bratisl Lek Listy. 2012;113(12):728-31. doi: 10.4149/bll_2012_165.

Results Reference

background

Links:

URL

http://turkcer.org.tr

Description

Turkish Surgical Association

Learn more about this trial

Modified Limberg Procedure Versus Lateral Advancement Flap With Burrow's Triangle Procedure in the Treatment of Pilonidal Sinus

We'll reach out to this number within 24 hrs